Quality of Artesunate Tablets Sold in Pharmacies in Kumasi, Ghana

K Ofori-Kwakye,Y Asantewaa,O Gaye

doi:10.4314/tjpr.v7i4.14704

Abstract

Purpose: The study was carried out to evaluate the quality of artesunate tablets sold in retail and wholesale pharmacies in Kumasi, Ghana. In particular, the study sought to ascertain the presence or otherwise of counterfeit artesunate tablets in Kumasi. Method: Artesunate tablets were purchased from pharmacies in Kumasi for the study. The mechanical properties of the tablets were evaluated, namely: uniformity of weight, breaking strength, friability and rate of disintegration in aqueous medium. Colorimetric methods were used to determine the presence of artesunate and to assay the tablets. Result: None of the artesunate tablets sampled was found to be a counterfeit. Most of the brands had acceptable mechanical properties in terms of mass uniformity, hardness, friability and disintegration time. However, the artesunate content of the tablets was variable (47.9-99.9 %). Six (35.3 %) of the samples passed the International Pharmacopoeia content uniformity test (93.7-99.9 %) while 11 (64.7 %) failed the test (47.9-89.4 %). However, only 3 (17.6 %) of the samples met the European Pharmacopoeia (Ph. Eur.) content requirements while 14 (82.4 %) failed to meet the requirements. Conclusion: The presence of substandard artesunate tablets on the Ghanaian market should alert drug regulatory authorities to be vigilant and continually monitor the quality of this life-saving drug. Keywords: Artesunate tablets, Artemisinins, Fast-red TR salt, Counterfeit drugs, Substandard drugs.Tropical Journal of Pharmaceutical Research Vol. 7(4) 2008: pp. 1179-1184

Highlights

Ofori-Kwakye et al INTRODUCTION Artesunate and other artemisinin derivatives such as artemether, and dihydroartemisinin are potent drugs which are used in the management of uncomplicated malaria
The use of any of the artemisinins as monotherapy has, been discouraged by the WHO to minimise the development of resistance to these new antimalarials
The WHO has since 2001 recommended the use of artemisininbased combination therapy (ACT) as first line malaria treatment in malaria-endemic African countries

Summary

Introduction

Artesunate and other artemisinin derivatives such as artemether, and dihydroartemisinin are potent drugs which are used in the management of uncomplicated malaria. The cure rate from monotherapy with artesunate and other artemisinin derivatives is low compared to the use of ACT3. In spite of the recommendation from the WHO, monotherapy with artesunate tablets is commonly employed in the management of malaria in Ghana and many other countries in Africa[4, 5]. Whether employed as monotherapy or as a component of ACT, artesunate plays a pivotal role in the global fight against malaria, there is the need to guarantee its quality and eliminate any form of fakery or counterfeiting. Already there have been several reports cataloguing the distribution and use of counterfeit and substandard artesunate tablets in many South-East Asian countries[611]. Cases of counterfeit and substandard artemisinins have been reported in African countries such as Tanzania, Cameroon 8, Kenya and the Democratic Republic of Congo[16]

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